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Effect of a Yoghurt Containing Four Probiotic Lactobacillus Strains on Bacterial Vaginosis

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ClinicalTrials.gov Identifier: NCT02744638
Recruitment Status : Completed
First Posted : April 20, 2016
Last Update Posted : November 17, 2016
Sponsor:
Collaborators:
Dairyfem R&D GmbH
University of Natural Resources and Life Sciences
Information provided by (Responsible Party):
Clinical Research Center Kiel GmbH

Brief Summary:
The aim of this study is, to investigate, whether the consumption of a probiotic yoghurt containing 4 probiotic strains naturally colonizing the vagina (L. crispatus, L. gasseri, L. rhamnosus, L. jensenii) has an influence on the comfort of adult women with BV after and 3 weeks following a standard antibiotic treatment with metronidazole.

Condition or disease Intervention/treatment Phase
Bacterial Vaginosis Other: probiotic yoghurt Other: chemically acidified milk Drug: Arilin Not Applicable

Detailed Description:
Female volunteers aged ≥18 years with stable menstrual cycle or postmenopausal women presenting with a newly diagnosed bacterial vaginosis based on Amsel criteria, complying with a standard oral antibiotic treatment (Metronidazol (Arilin®) 7 days 2x500mg), willing to consume for 4 weeks the study product two times daily, complying with the dietary restrictions (s. a.) and complying with the other inclusion and exclusion criteria will be enrolled in the study. After enrollment subjects will be randomly and evenly assigned to one of the two test groups verum and placebo.The study population will be recruited in a screening examination (G1) by gynaecologists from Kiel area. This screening examination (routine examination) by gynaecologist is used to provide the diagnosis BV. After enrolment subjects will be randomly assigned to one of the two test groups verum (n=108) and placebo (n=108).

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Double-blind, Randomized, Controlled Trial to Evaluate the Effect of a Yoghurt Containing Four Probiotic Lactobacillus Strains (L. Crispatus, L. Gasseri, L. Rhamnosus, L. Jensenii) on Bacterial Vaginosis (BV) in Adult Women
Study Start Date : February 2015
Actual Primary Completion Date : August 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaginal Diseases
U.S. FDA Resources

Arm Intervention/treatment
Experimental: probiotic yoghurt & Arilin
probiotic yoghurt, 2 units (125 g), containing living strains of L.crispatus, L.gasseri, L.rhamnosus, L.jensenii, each in a concentration of 1 x 107 CFU/ml product for 4 weeks Two yoghurts are consumed every day for 28 days. 2 tablets Metronidazol 500mg daily for 7 days
Other: probiotic yoghurt
verum is a liquid probiotic yoghurt containing all four probiotics as described in the arm description. Study participants consume daily two bottles (125g) during an intervention period of four weeks.
Other Name: verum
Drug: Arilin
2 tablets Arilin 500mg for 7 days
Other Name: Metronidazol
Placebo Comparator: chemically acidified milk & Arilin
chemically (H3PO4) acidified milk (125g) without bacterial strains. Two products are consumed every day for 28 days. 2 tablets Metronidazol 500mg daily for 7 days
Other: chemically acidified milk
Placebo is chemically acidified milk without bacterial strains. Study participants consume daily two bottles (125g) during an intervention period of four weeks (randomly assigned).
Other Name: placebo
Drug: Arilin
2 tablets Arilin 500mg for 7 days
Other Name: Metronidazol



Primary Outcome Measures :
  1. Rate of BV-free woman [ Time Frame: 4 weeks ]
    The rate of BV-free women at the end of the yoghurt consumption period (day 28) as assessed by Nugent score


Secondary Outcome Measures :
  1. Alteration (G2 - G1) of Nugent Score [ Time Frame: 4 weeks ]
  2. Alteration (G2 - G1) of symptom score based on Amsel criteria (Yes=1; No=0) and 3 (Yes=1; No=0) resulting in a score ranging from 0 to 2 [ Time Frame: 4 weeks ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

To be enrolled, the following criteria have to be fulfilled:

  1. Woman aged ≥ 18 years with stable menstrual cycle or postmenopausal women
  2. Newly diagnosed bacterial vaginosis based on Amsel criteria
  3. Complies with a standard oral antibiotic treatment with Metronidazol for 7 days, 2 x 500mg/day)
  4. Willing to consume for 4 weeks the study product two times daily
  5. Willingness to abstain from food and supplements containing probiotics, prebiotics and other fermented products as well as dietary supplements
  6. Not in menses at the time of the first examination at the gynaecologist (G1)
  7. Written informed consent

Exclusion Criteria:

  1. Subjects currently enrolled in another clinical study.
  2. Subjects having finished another clinical study within the last 4 weeks before inclusion.
  3. Infection caused by Chlamydia trachomatis
  4. Infection caused by Neisseria gonorrhoea
  5. Infection caused by Trichomonas vaginalis
  6. Infection caused by Candida albicans or other mycosis
  7. Leucocytes present in the vaginal smear
  8. PAP-testing ≥ 3 (anamnestically)
  9. Vulvovaginal inflammation as macroscopically identified by the gynaecologist
  10. Dyspareunia
  11. Pregnancy and breastfeeding
  12. Chemically based contraceptives (e.g. suppositories, salves, foam, gel)
  13. Irregular cycles (e.g. polymenorrhoea, metrorrhagia)
  14. Dysuria
  15. Infection of the urinary tract
  16. Chronic or sporadic abdominal pain with exception of dysmenorrhoea
  17. Any ano-rectal infection, disease, surgery in the medical history or current
  18. Anus praeter
  19. Hypersensitivity, allergy or idiosyncratic reaction to metronidazole or any similar active substances.
  20. Hypersensitivity, allergy or idiosyncratic reaction to any component of the yoghurt (e.g. lactose intolerance, allergy against milk protein)
  21. Any disease or condition which might compromise significantly the hematopoietic, renal, endocrine, pulmonary, hepatic, gastrointestinal, cardiovascular, immunological, central nervous, dermatological or any other body system with the exception of the conditions defined by the inclusion criteria.
  22. History of hepatitis B and C
  23. History of HIV infection
  24. Regular medical treatment including OTC, which may have impact on the study aims (e.g. probiotics, antibiotic drugs, laxatives etc.)
  25. Major cognitive or psychiatric disorders
  26. Subjects who are scheduled to undergo hospitalization during the study period
  27. Eating disorders (e.g. anorexia, bulimia) or special diets (e.g. vegan, vegetarian)
  28. Present drug abuse or alcoholism, reformed alcoholic
  29. Legal incapacity

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02744638


Locations
Germany
CRC Clinical Research Center Kiel
Kiel, Schleswig-Holstein, Germany, 24118
Sponsors and Collaborators
Clinical Research Center Kiel GmbH
Dairyfem R&D GmbH
University of Natural Resources and Life Sciences
Investigators
Principal Investigator: Christiane Laue, Dr. med. CRC Clinical Research Center Kiel

Responsible Party: Clinical Research Center Kiel GmbH
ClinicalTrials.gov Identifier: NCT02744638     History of Changes
Other Study ID Numbers: DF-WCT-2014
First Posted: April 20, 2016    Key Record Dates
Last Update Posted: November 17, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Clinical Research Center Kiel GmbH:
bacterial vaginosis
probiotics
Amsel Score
Nugent Score

Additional relevant MeSH terms:
Vaginal Diseases
Vaginosis, Bacterial
Genital Diseases, Female
Bacterial Infections
Vaginitis
Metronidazole
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents